What is PREZCOBIX®?
PREZCOBIX® is a prescription medicine that is used with other HIV-1 medicines to treat HIV-1 infection in adults and in children who weigh at least 88 pounds (40 kg). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). PREZCOBIX® contains prescription medicines darunavir and cobicistat. It is not known if PREZCOBIX® is safe and effective in children weighing less than 88 pounds (40 kg).
Important Safety Information
What is the most important information I should know about PREZCOBIX®?
PREZCOBIX® may cause liver problems which may be life-threatening. Tell your healthcare provider right away if you have any symptoms such as:
- Dark (tea-colored) urine
- Yellowing of your skin or the whites of your eyes
- Pale-colored stools (bowel movements)
- Pain or tenderness on your right side below your ribs
- Loss of appetite
PREZCOBIX® may cause severe or life-threatening skin reactions or rashes. Stop taking PREZCOBIX® and call your healthcare provider right away if you develop any skin changes with symptoms below:
- Muscle or joint pain
- Blisters or skin lesions
- Mouth sores or ulcers
- Red or inflamed eyes, like "pink eye" (conjunctivitis)
- PREZCOBIX®, when taken with some other medications, can cause new or worse kidney problems, including kidney failure.
- Do not take PREZCOBIX® with any medicine that contains: alfuzosin, carbamazepine, cisapride, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, dihydroergotamine, ergotamine tartrate, ivabradine, lomitapide, lovastatin, lurasidone, methylergonovine, midazolam (when taken by mouth), naloxegol, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, St. John's wort (Hypericum perforatum), sildenafil when used for pulmonary arterial hypertension (PAH), simvastatin, or triazolam.
- Serious problems can happen if you take any of these medicines with PREZCOBIX®.
What should I tell my healthcare provider before taking PREZCOBIX®?
Tell your healthcare provider about all your medical conditions, including if you:
- have liver problems, including hepatitis B or hepatitis C, have kidney problems, are allergic to sulfa (sulfonamide), have diabetes, or have hemophilia.
are pregnant, or plan to become pregnant. It is not known if PREZCOBIX® will harm your unborn baby. PREZCOBIX® should not be used during pregnancy because the PREZCOBIX® levels in your blood may be lower during pregnancy and may not control your HIV-1. Tell your healthcare provider right away if you become pregnant during treatment with PREZCOBIX®. Your healthcare provider will prescribe different medicines if you become pregnant during treatment with PREZCOBIX®.
- Hormonal forms of birth control, such as injections, vaginal rings or implants, contraceptive patches, and some birth control pills may not work during treatment with PREZCOBIX®. Talk to your healthcare provider about forms of birth control that may be used during treatment with PREZCOBIX®.
- are breastfeeding, or plan to breastfeed. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. It is not known if PREZCOBIX® can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with PREZCOBIX®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.
What are the possible side effects of PREZCOBIX®?
PREZCOBIX® may cause serious side effects including:
- See “What is the most important information I should know about PREZCOBIX®?”
- Diabetes and high blood sugar
- Changes in body fat can happen in people taking HIV-1 medications
- Immune system changes can happen in people who start HIV medications
- Increased bleeding can occur in people with hemophilia who are taking PREZCOBIX®
The most common side effects include:
- Stomach area (abdominal) pain
These are not all the possible side effects of PREZCOBIX®. Call your doctor for medical advice about side effects. For more information, ask your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).
Please read full Product Information for PREZCOBIX® for more details.